Device |
assay, enterovirus nucleic acid |
Definition |
Consists of primers, probes, enzymes and controls for the amplification and detection of enterovirus RNA in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis. The detection of enterovirus RNA, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of viral meningitis caused by enterovirus. |
Product Code | OAI |
Regulation Number |
866.3225
|
Device Class |
2
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